Device and method for improving the function of a heart valve

ABSTRACT

A device for improving the function of a heart valve comprises: a support member formed from a shape memory material, and a restraining member providing a restraining action on a course of the support member. The support member may abut one side of the valve conforming to the shape of the valve annulus upon said shape memory material assuming an activated shape while the restraining member restrains the course of the support member. The restraining action is removable for allowing the support member to assume a desired, altered course. The restraining member may be biodegradable to be degraded within a patient or may be detachable from the support member to be withdrawn. The support member according to another embodiment presents a shape change in that an increased cross-section is associated with a shortened length of the support member. The support member according to yet another embodiment has a first and a second activated shape.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/880,007 filed Sep. 10, 2010 entitled A Device And Method ForImproving The Function Of A Heart Valve, which is a divisional of U.S.patent application Ser. No. 12/065,884 filed Sep. 3, 2008 entitled ADevice And Method For Improving The Function Of A Heart Valve, now U.S.Pat. No. 8,128,691 issued Mar. 6, 2012, which claims priority toInternational Patent Application No. PCT/SE2006/001019 filed Sep. 5,2006 entitled A Device And Method For Improving The Function Of A HeartValve, which in turns claims priority to Swedish Patent Application No.0501993-0 filed Sep. 7, 2005 entitled A Device And Method For ImprovingThe Function Of A Heart Valve, all of which are hereby incorporated byreference.

FIELD OF THE INVENTION

The present invention generally relates to heart valve repair andannuloplasty devices. More specifically, the invention relates to therepair of heart valves having various malformations and dysfunctions.

BACKGROUND OF THE INVENTION

Diseased mitral and tricuspid valves frequently need replacement orrepair. The mitral and tricuspid valve leaflets or supporting chordaemay degenerate and weaken or the annulus may dilate leading to valveleak (insufficiency). The leaflets and chords may become calcified andthickened rendering them stenotic (obstructing forward flow). Finally,the valve relies on insertion of the chordae inside the ventricle. Ifthe ventricle changes in shape, the valve support may becomenonfunctional and the valve may leak.

Mitral and tricuspid valve replacement and repair are traditionallyperformed with a suture technique. During valve replacement, sutures arespaced around the annulus (the point where the valve leaflet attaches tothe heart) and then the sutures are attached to a prosthetic valve. Thevalve is lowered into position and when the sutures are tied, the valveis fastened to the annulus. The surgeon may remove all or part of thevalve leaflets before inserting the prosthetic valve. In valve repair, adiseased valve is left in situ and surgical procedures are performed torestore its function. Frequently an annuloplasty ring is used to reducethe size of the annulus. The ring serves to reduce the diameter of theannulus and allow the leaflets to oppose each other normally. Suturesare used to attach a prosthetic ring to the annulus and to assist inplicating the annulus.

In general, the annuloplasty rings and replacement valves must besutured to the valve annulus and this is time consuming and tedious. Ifthe ring is severely malpositioned, then the stitches must be removedand the ring repositioned relative to the valve annulus duringrestitching. In other cases, a less than optimum annuloplasty may betolerated by the surgeon rather than lengthening the time of the surgeryto restitch the ring.

During heart surgery, a premium is placed on reducing the amount of timeused to replace and repair valves as the heart is frequently arrestedand without perfusion. It would therefore be very useful to have amethod to efficiently attach a prosthesis into the mitral or tricuspidvalve position.

In U.S. Pat. No. 6,419,696, an annuloplasty device is disclosed. Thedevice comprises a first and a second support ring configured to abutopposite sides of the valve annulus to thereby trap valve tissuetherebetween. The device may be used in those situations that haveconventionally utilized annuloplasty rings, but the device may beapplied in a much easier manner by rotating the rings into position onopposite sides of the valve annulus.

OBJECTS AND SUMMARY OF THE INVENTION

It is an object of the invention to provide a more reliable and moreeasily accomplished valve repair. It is a specific object of theinvention to facilitate insertion of an annuloplasty implant.

These and other objects of the invention are accomplished by means of adevice and a method according to the independent claims. Preferredembodiments of the invention are apparent from the dependent claims.

Thus, according to a first aspect of the invention, there is provided adevice for improving the function of a heart valve comprised of valvetissue including an annulus and a plurality of leaflets for allowing andpreventing blood flow. The device comprises a support member at leastpartially formed from a shape memory material operable to assume anactivated shape and an inactivated shape and a restraining member, whichis arranged to provide a restraining action on a course of the supportmember. The support member is configured to abut one side of the valveand is arranged to conform to the shape of at least a part of the valveannulus upon said shape memory material assuming said activated shapewhile the restraining member exerts the restraining action on the courseof the support member. The restraining member is formed of abiodegradable material to be degraded when the device is implanted in apatient, wherein degradation of the restraining member removes therestraining action and allows the support member to assume a desired,altered course.

According to a second aspect of the invention, there is provided adevice for improving the function of a heart valve comprised of valvetissue including an annulus and a plurality of leaflets for allowing andpreventing blood flow. The device comprises a support member beingconfigured to abut one side of the valve and being arranged to conformto the shape of at least a part of the valve annulus. The support memberhas an inherent adaptation to a shape change such that an increasedcross-section of at least part of the support member is associated witha shortened length of the support member, whereby the support member issusceptible to an expansion of a cross-section of the support memberwhen the support member has conformed to the shape of at least part ofthe valve annulus such that the support member assumes a desired,altered shape.

According to a third aspect of the invention, there is provided a devicefor improving the function of a heart valve comprised of valve tissueincluding an annulus and a plurality of leaflets for allowing andpreventing blood flow. The device comprises a support member at leastpartially formed from a shape memory material operable to assume a firstactivated shape, a second activated shape and an inactivated shape. Thesupport member is configured to abut one side of the valve and isarranged to conform to the shape of at least a part of the valve annulusupon said shape memory material assuming said first activated shape. Thesupport member is further configured to assume a desired, altered coursefor remodelling the valve annulus upon said shape memory materialassuming said second activated shape. The shape memory material isarranged such that heating the shape memory material to a firsttemperature will bring the shape memory material to assume said firstactivated shape and further heating of the shape memory material to asecond temperature will bring the shape memory material to assume saidsecond activated shape.

According to a fourth aspect of the invention, there is provided adevice for improving the function of a heart valve comprised of valvetissue including an annulus and a plurality of leaflets for allowing andpreventing blood flow. The device comprises a support member at leastpartially formed from a shape memory material operable to assume anactivated shape and an inactivated shape and a restraining member, whichis arranged to provide a restraining action on a course of the supportmember. The support member is configured to abut one side of the valveand is arranged to conform to the shape of at least a part of the valveannulus upon said shape memory material assuming said activated shapewhile the restraining member exerts the restraining action on the courseof the support member. The restraining member is detachable from thesupport member for releasing the restrain and allowing the supportmember to assume a desired, altered course.

According to all four aspects of the invention, the support member maybe arranged in a configuration to abut one side of the valve conformingto the shape of at least a part of the valve annulus. The support membermay also assume a desired, altered shape. According to all four aspectsof the invention, the device provides a possibility of controlling whenthe support member is to assume the desired, altered shape. This impliesthat the support member may be fixed to the valve before assuming thedesired, altered shape. Thus, all four aspects of the invention providea possibility to control when the support member assumes the desired,altered shape.

According to the first and fourth aspects of the invention, therestraining member delays the support member from assuming thememorized, desired shape. The restraining member allows the supportmember to conforming to the shape of at least a part of the valveannulus, but it prevents the support member from assuming the desiredcourse. This implies that the support member may be firmly anchored tothe valve tissue before the support member assumes the desired course.Thus, when the restraining action is removed to release the restrain onthe support member, the support member will bring the valve tissue withit in assuming the desired course. The shape change of the supportmember may be designed such that valve tissue is drawn towards theopening in the valve in order for the valve to be remodelled forallowing the valve leaflets to close properly.

The support member may have an initial shape, when inserted to the heartvalve, that conforms to the shape of a dilated annulus. Thus, there isno need for forcing the heart valve to a remodelled shape when thesupport member is to be attached to the valve. This implies that thesupport member may be more easily attached to the valve, especially whenoperating on a beating heart. After the support member has been firmlyattached to the valve, the shape change may be allowed such that theremodelling of the heart valve is performed.

Since the restraining member is biodegradable for removing therestraining action according to the first aspect of the invention, thesupport member may be firmly anchored to the valve tissue by overgrowthof endothelial cells while the restraining member is degraded. Thus,when the restraining member has been degraded to release the restrain onthe support member, the support member will bring the valve tissue withit in assuming the desired course. Further, the surgeon may leave boththe support member and the restraining member in the patient afterimplantation and the degradation will be performed by the immune systemof the patient acting on the restraining member.

According to the second aspect of the invention, the change of shape ofthe support member may be actively controlled by providing a force toincrease its cross-section. Thus, the support member may be fixed to thevalve before a force is applied to increase the cross-section. Thesupport member is suited to conform to the shape of at least a part ofthe valve annulus, but it will not unaffected increase its cross-sectionto assume the desired shape. This implies that the support member may befirmly anchored to the valve tissue before the support member isaffected for assuming the desired shape. Thus, when an increase of thecross-section is created, the support member will bring the valve tissuewith it in assuming the desired shape. As the support member shortens,the shape change of the support member may be designed such that valvetissue is drawn towards the opening in the valve in order for the valveto be remodelled for allowing the valve leaflets to close properly.

The support member may have an initial shape, when inserted to the heartvalve, that conforms to the shape of a dilated annulus. Thus, there isno need for forcing the heart valve to a remodelled shape when thesupport member is to be attached to the valve. This implies that thesupport member may be more easily attached to the valve, especially whenoperating on a beating heart. After the support member has been firmlyattached to the valve, the shape change may be allowed such that theremodelling of the heart valve is performed.

The cross-section of the support member may be increased at specificportions of the support member. The increase of the cross-section isdirected to portions that are particularly suitable for treating theheart valve. The decision on which portions to be manipulated is basedon the shape of the heart valve and the desired remodelling of the heartvalve. Thus, the device allows control of the remodelling of the heartvalve that is created by increasing the cross-section locally. However,the cross-section of the support member may alternatively be increasedalong the entire support member such that a general shortening of thesupport member is achieved for treating the heart valve symmetrically.

According to the third aspect of the invention, the change of shape ofthe support member may be actively controlled by controlling thetemperature of the support member. Thus, the support member may be fixedto the valve while the support member is maintained in the firstactivated shape by keeping the temperature of the support member abovesaid first temperature but below said second temperature. This impliesthat the support member may be firmly anchored to the valve tissuebefore the support member is heated for assuming the desired shape.Thus, when the support member is heated to assume its second activatedshape, the support member will bring the valve tissue with it inassuming the desired shape. As the support member assumes its desiredshape, the shape change of the support member may be designed such thatvalve tissue is drawn towards the opening in the valve in order for thevalve to be remodelled for allowing the valve leaflets to closeproperly.

According to the fourth aspect of the invention, the restraining memberis detachable from the support member for removing the restrainingaction. This implies that a surgeon may actively detach and withdraw therestraining member after the support member has been properly attachedto the valve tissue.

The invention according to any of the four aspects contemplates variousembodiments of the device, including embodiments for catheter-basedsurgery and embodiments for open heart surgery.

According to the first and fourth aspects of the invention, the supportmember may be arranged to be brought into the activated shape byreceiving induced heating at selective portions of the support member.Thus, the support member may be inserted to a desired position in theinactivated shape and the shape of the support member during insertionis controlled both by the restraining member and the support member notstriving towards assuming the desired course. By selectively heating thesupport member, selective portions of the support member may be broughtto the activated shape and the heating controls what shape the supportmember will assume. The selective heating may be accomplished by acatheter with a heating element, which may be brought in contact withselective parts of the support member. The heating of the support memberwill initiate a strive of the support member to assume the activatedshape. In order to facilitate placement and attachment of the supportmember to the heart valve, the support member may be firmly attached tothe valve before the support member is heated.

According to all four aspects of the invention, the support member maybe arranged to assume a reduced radius of curvature in the alteredshape. This implies that the valve annulus may be remodelled such thatit is moved inwards and the valve opening is decreased for ensuring thatthe valve leaflets close properly. However, other changes of the courseof the support member may be contemplated for treating a diseased heartvalve. For example, the course of the support member may be changed suchthat a radius of curvature is increased locally. Further, the course ofthe support member may be changed to introduce a depression or recess inthe course of the support member. This implies that the support member,if applied on the atrial side of the heart valve, may push a leaflettowards the heart ventricle and, thereby, prevent a prolapsing leafletfrom extending into the heart atrium.

According to the first aspect of the invention, the restraining membermay be formed so as to control the rate of degradation in a patient. Therestraining member may be arranged to degrade within a few weeks ofimplantation in a patient. This implies that the support members will befirmly attached to the valve by the time the restraining member isdegraded. The degradation period of the restraining member may becontrolled by the thickness and the material of the restraining member.

According to all four aspects of the invention, the support member maybe a first support member and the device may further comprise a secondsupport member at least partially formed from said shape memory materialand connected to said first support member. The second support member isconfigured to abut an opposite side of the valve, whereby a portion ofthe valve tissue may be trapped between said first and second supportmembers.

Such a device having a first and a second support member is applied tothe heart valve in a much easier manner than conventionally utilizedannuloplasty rings. The device may be rotated into place arranging thefirst and second support members on opposite sides of the heart valve.The support members trap valve tissue between them and thereby also atleast partly attach the support members to the heart valve.

The first and second support members act to support valve tissue onopposite sides for e.g. aiding prolapsing leaflets to close properly.The first and second support members also act to remodel the valve,after the restraining action has been removed, in order to bring theleaflets closer to each other and thereby help the leaflets to closeproperly.

The shape of the second support member may be controlled in the samemanner as the shape of the first support member. Thus, when arestraining action is removed or a desired shape of the support membersis activated, both the first and the second support members may altercourse for bringing valve tissue with them and remodel the heart valve.Alternatively, only one of the support members is restrained fromassuming the desired course. However, this restrain may also prevent theother support member from fully assuming its desired course.

The first and second support members may be loop-shaped. As used herein,the term “loop-shaped” should be construed as a curved shape that may beclosed as a ring with a circular, elliptic, or D-shaped form or anyother closed form which may fit the shape of the valve annulus. The term“loop-shaped” also includes a curved shape that is open forming anarcuate shape, such as a C-shape or U-shape, which includes an angularturn of at least 180° such that the support member may abut valve tissuealong a major part of the annular valve shape. The term “loop-shaped”also includes a curved shape that allows overlapping itself to form aportion of a coil.

The first loop-shaped support member may thus be continuous with thesecond loop-shaped support member to form a coil-shape. This facilitatesrotating the support members into position on opposite sides of theheart valve. An end of the coil-shape may be brought to a commissurebetween leaflets of the heart valve and the coil-shape may be rotatedsuch that the support members are placed on opposite sides of the valve.

The first and second support members may be D-shaped. Such shape wouldconform to the shape of the atrial valve annulus and is thereforeespecially useful for treatment of atrial valves.

At least the opposed surfaces of the first and second support membersmay be roughened, such as by the use of fabric, coatings, knurling orthe like to facilitate better engagement and retention of the supportmembers on the valve tissue. The opposed surfaces may be roughened in apattern extending along the longitudinal direction of the loop-shape ofthe support members. This implies that the roughened surface will serveto prevent slippage of tissue through the pinch of the support memberson opposite sides of the valve while presenting a low friction for thesupport members to be turned into position abutting the valve.

An outer boundary of the second support member may be greater than anouter boundary of the first support member. This implies that thedevice, when properly positioned at a heart valve, may be arranged suchthat the first and second support members are displaced to one anotheron the opposite sides of the heart valve. It has been found that thisarrangement diminishes a risk that a rupture is created in the leaflets,which during normal heart action bends over the lower support member toopen the valve. A possible explanation for this diminished rupture riskis that since the support members are displaced to one another, thepinch between the first and second support members does not sharplydefine a radial position in which the leaflets of the valve bend overthe lower support member. When using the device on an atrial valve, thelower support member may now be arranged close to the annulus of thevalve, which is larger on its ventricular side. Thereby, the device mayalso be arranged to minimally affect the movement of the leaflets duringnormal heart action. Further, a large lower support member provides apossibility to move the support member around the chords in the leftventricle during insertion of the device. However, it is conceivablethat the diminished rupture risk may be achieved by instead making theouter boundary of the upper support member greater than the outerboundary of the lower support member.

According to the fourth aspect of the invention, the restraining membermay be coil-shaped. This implies that the restraining member may bearranged to follow the shape at opposite sides of the heart valve formaintaining a large radius of curvature of the support members at bothsides of the heart valve.

The first and second support members may be wound around the restrainingmember forming a helix having a global coil-shape. Thus, the restrainingmember forms an inner coil-shaped core inside a helix. This core willprevent the support members from assuming the desired radius. When thecore is degraded, the support members are allowed to assume a coil-shapewith a decreased radius.

Many other alternative embodiments of the restraining member areconceivable. For example, the restraining member may comprise one ormore pins or bars extending between different positions on the supportmember and thus forcing these positions to be at a fixed distance toeach other. According to another alternative, the support member istubular and the restraining member is elongate and extendable throughthe tubular support member for exerting said restraining action. Therestraining member may then be withdrawn from inside the tubular supportmember to release the restraining action.

According to the second aspect of the invention, the first and secondsupport members may be tubular. Alternatively, the first and secondsupport members may have a U-shaped cross-section. A support memberpresenting a tubular or U-shaped cross-section may be exposed to anoutwardly pressing force such that the cross-section is increased inradial direction.

The first and second support members may be adapted to receive a balloontherein for expanding the cross-section of at least part of the supportmember. The balloon may suitably be used for insertion inside thesupport member and, upon inflation, provide an outwardly pressing forcefor increasing the cross-section.

As another alternative, the first and second support members may bebelt-shaped. The cross-section of the belt may be increased by pullingthe sides of the belt apart.

The first and second support members may be formed from a mesh-likestructure. Such a structure may provide a possibility to alter thecross-section of the support member while changing the length of thesupport member. Suitably, the first and second support members may bestents.

According to a fifth aspect of the invention, there is provided a methodfor improving the function of a heart valve comprised of valve tissueincluding an annulus and a plurality of leaflets for allowing andpreventing blood flow. The method comprises inserting an implantationdevice comprising a support member, wherein the implantation device isinserted such that the support member abuts one side of the valve. Thesupport member is arranged along a first course conforming to the shapeof at least part of the valve annulus. The method further comprisesattaching the support member to valve tissue for fixating the positionof the support member relative to the valve. The method furthercomprises activating a shape change of the support member such that thesupport member assumes a desired, altered course in order to remodel theheart valve.

According to the method, a device having an inherent possibility tochange its shape is inserted into the heart valve of a patient. Thedevice is properly attached to the heart valve conforming to the shapeof at least part of the valve annulus before the shape change isactivated. Thus, the method provides a possibility of allowing thesupport member to be firmly fixed to the valve tissue before the shapeof change takes place and, therefore, the support member will bring thevalve tissue with them in the change of shape for remodelling the heartvalve. The method provides attaching a support member conforming to ashape of a dilated valve annulus before remodelling of the heart valve.This implies that the support member may be more easily attached to thevalve, especially when operating on a beating heart.

According to one embodiment, the support member is at least partiallyformed from a shape memory material operable to assume an activatedshape and an inactivated shape, and the implantation device furthercomprises a restraining member, which is arranged to provide arestraining action on a course of the support member. The insertioncomprises bringing the shape memory material of the support member to anactivated shape such that the support member is arranged along the firstcourse while the restraining member exerts the restraining action on thesupport member. In this embodiment, the support member has an inherentstrive to assume the desired course. However, the point of time of theshape change of the support member is controlled by means of therestraining member, such that the support member may be attached to theheart valve before it assumes the desired course.

In this embodiment, the activating comprises removing the restrainingaction of the restraining member allowing the support member to assumethe desired, altered course.

The removing may comprise withdrawing the restraining member from theinserted implantation device. Thus, the restraining member may bearranged such that it may be withdrawn from the patient leaving thesupport member in position to assume the desired course.

Alternatively, the restraining member may be biodegradable and theremoving may comprise leaving the support member and the restrainingmember in the patient in order for the restraining member to be degradedand remove the restraining action. This implies that the support membermay be firmly anchored to the valve tissue by overgrowth of endothelialcells while the restraining member is degraded. Thus, when therestraining member has been degraded to release the restrain on thesupport member, the support member will bring the valve tissue with itin assuming the desired course.

According to another embodiment, the support member has an inherentadaptation to a shape change such that an increased cross-section of atleast part of the support member is associated with a shortened lengthof the support member. The activating comprises expanding thecross-section of the support member such that the support member isshortened and assumes the desired, altered course. In this embodiment,the support member will not change shape until affected by a force forexpanding a cross-section of the support member. Thus, the point of timeof the shape change of the support member is controlled, such that thesupport member may be attached to the heart valve before it assumes thedesired course.

The support member may be tubular or U-shaped and the expanding maycomprise bringing a balloon in contact with at least part of the supportmember and inflating the balloon such that the cross-section of thesupport member is increased.

The support member may be a first support member and the implantationdevice may further comprise a second support member connected to thefirst support member. The insertion may further comprise placing saidimplantation device such that the second support member abuts anopposite side of the valve, the second support member being arrangedalong a first course conforming to the shape of at least part of thevalve annulus at said opposite side.

The attaching may partly comprise placing the first and second supportmembers in relation to each other on opposite sides of the heart valvesuch that a portion of the valve tissue is trapped between said firstand second support members. The first and second support members may atleast prevent the valve tissue from slipping through the pinch betweenthe support members and altering the relation of the support members tothe heart valve during fixation of the support members to the heartvalve.

The activating may comprise activating a shape change of the secondsupport member such that the second support member also assumes adesired, altered course in order to remodel the heart valve. Thisimplies that the heart valve is treated from both sides and that thepinch of the valve tissue may be maintained after the support membershave assumed the desired course.

The step of inserting may comprise inserting a first end of the firstsupport member through a portion of the valve tissue, rotating theimplantation device to position the first support member on a first sideof the valve, and positioning the second support member on an oppositesecond side of the valve. The first and second support members are thuseasily applied on opposite sides of the valve.

The step of inserting may further comprise introducing the implantationdevice into the patient inside a catheter. Thus, the implantation devicemay be introduced in a low invasive manner.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described in further detail by way of exampleunder reference to the accompanying drawings.

FIG. 1 schematically illustrates a patient with a heart shown incross-section and a device of the present invention schematicallyillustrated as supporting the mitral valve.

FIG. 1A is a cross-sectional view of the left ventricle showing themitral valve in perspective.

FIG. 2 is a perspective view of a device according to a first embodimentof the invention, wherein first and second support members of the deviceare shown in an inactivated shape suitable for insertion into a patient.

FIG. 3 is a perspective view of the device in FIG. 2, wherein the firstand second support members have assumed an activated shape but arerestrained by a restraining member.

FIG. 4 is a perspective view of the device in FIG. 2, wherein the firstand second support members have assumed a desired, activated shape afterrelease of the restrain from the restraining member.

FIG. 5 is a perspective view of an alternative device according to thefirst embodiment of the invention.

FIG. 6 is a perspective view of the device of FIG. 5 having assumed adesired, activated shape.

FIG. 7 is a perspective view of yet another alternative device accordingto the first embodiment of the invention.

FIG. 8 is a perspective view of the device of FIG. 8 having assumed adesired, activated shape.

FIG. 9 is a cross-sectional view of the device in FIG. 4.

FIG. 10 is a perspective view of a device according to a secondembodiment of the invention, wherein first and second support members ofthe device are shown in a first shape having a small cross-section.

FIG. 11 is a perspective view of the device in FIG. 10, wherein thecross-section has been increased and the first and second supportmembers have assumed an altered shape.

FIGS. 12a-c are cross-sectional views of the device according to thesecond embodiment.

FIG. 13 is a perspective view of a device according to a thirdembodiment of the invention, wherein the device is in an inactivatedshape.

FIG. 14 is a perspective view of the device in FIG. 13, wherein thedevice is in a first activated shape.

FIG. 15 is a perspective view of the device in FIG. 13, wherein thedevice is in a second activated shape.

FIG. 16 is a perspective view of a device according to a fourthembodiment of the invention, wherein the device comprises only onesupport member.

FIG. 17 is a perspective view of the device in FIG. 16, wherein thedevice has assumed an altered shape.

FIGS. 18a-b are partially sectioned perspective views of the mitralvalve and the device according to the first embodiment of the inventionduring implantation of the device.

FIG. 19 is a partially sectioned perspective view showing the device ofthe invention after having been turned into position.

FIGS. 20a-b are cross-sectional views illustrating fixation of thedevice to the heart valve.

FIG. 21 is a cross-sectional view of the implanted device in FIG. 18.

FIG. 22 is a perspective view showing the implanted device after therestraining member has been degraded.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates a patient 10 having a heart 12 shown in cross-sectionincluding a left ventricle 14 and a right ventricle 16. The concepts ofthe present invention are suitable to be applied, for example, to amitral valve 18 which supplies blood into left ventricle 14. Mitralvalve 18, as better shown in FIG. 1A, includes an annulus 20 and a pairof leaflets 22, 24 which selectively allow and prevent blood flow intoleft ventricle 14. It will be appreciated that the term valve tissue isused extensively throughout this disclosure in reference to thedrawings. The inventive principles are equally applicable when referringto any valve tissue such as annulus tissue, leaflet tissue or otherattached vessel tissue. Leaflets 22, 24 are supported for coaptation bychordae tendinae or chords 26, 28 extending upwardly from respectivepapillary muscles 30, 32. Blood enters left ventricle 14 through mitralvalve 18 and is expelled during subsequent contraction of heart 12through aortic valve 34. It will be appreciated that the presentinvention is applicable to tricuspidal heart valves as well.

A device 40 according to a first embodiment of the present invention isshown in FIGS. 2-4. The device comprises a first and a second supportmember 42, 44. The first support member 42 is continuous with the secondsupport member 44. The first and second support members 42, 44 areformed from a shape memory material, such as alloys based on e.g.Nitinol, copper-zinc-aluminium, or copper-aluminium-nickel, or a shapememory polymer, which may be polynorborene-, polyisoprene-, styrenebutadiene-, and polyurethane-based materials and vinyl acetate- andpolyester-based compounds.

The first and second support members 42, 44 have an inactivated shapeand an activated shape. In the inactivated shape, the support members42, 44 are flexible and may be easily deformed. In the activated shape,the support members 42, 44 have a strong strive towards assuming adesired, preprogrammed shape. The support members 42, 44 may enter anactivated shape by being exposed to a temperature above a transitiontemperature. Thus, the device 40 may be inserted in a low invasivemanner, the support member 42, 44 being in the inactivated shape. Thedevice 40 may then assume the desired shape when placed in the properposition in the patient by the support members 42, 44 being brought totheir activated shape. The support members 42, 44 may be arranged to bebrought into the activated shape by receiving induced heating atselective portions of the support members 42, 44. By selectively heatingthe support members 42, 44, selective portions of the support members42, 44 may be brought to the activated shape and the heating controlswhat shape the support members 42, 44 will assume. The selective heatingmay be accomplished by a catheter with a heating element, which may bebrought in contact with selective parts of the support members 42, 44.

The device 40 further comprises a restraining member 45. The restrainingmember 45 is arranged to prevent the support members 42, 44 from fullyassuming the desired activated shape. The restraining member 45 iscoil-shaped and is formed from a biodegradable material, such as amaterial based on polyglycolic acid, copolymers of glycolic acid andlactic acid, or various lactide polymers. The biodegradable materialwill be degraded or resorbed when implanted in a patient. The timeperiod for degradation will depend on the particular material and thethickness of the restraining member 45. Thus, this may be controlled bythe design of the restraining member 45.

As shown in FIGS. 2-3, the first and second support members 42, 44 maybe wound around the restraining member 45. This allows the restrainingmember 45 to restrain the support members 42, 44 from assuming thepreprogrammed shape. As shown in FIG. 2, the device 40 may be arrangedin a generally elongate shape in the inactivated shape of the supportmembers 42, 44. This elongate shape is suitable for placing the device40 inside a catheter for insertion into a patient. The coil-shapedrestraining member 45 is thus stretched out for allowing it to be placedinside a catheter.

In FIG. 3, the device 40 is shown with the support members 42, 44 beingin an activated shape. The restraining member 45 has assumed itscoil-shape and prevents the support members 42, 44 from fully obtainingthe activated shape. The restraining member 45 forces the supportmembers 42, 44 to follow a coil-shape having a larger radius ofcurvature than the preprogrammed shape.

When implanted in a patient, the restraining member 45 will be degraded.In FIG. 4, the device 40 is shown after the restraining member 45 hasbeen degraded and the first and second support members have fullyassumed the activated, preprogrammed shape. The first and second supportmembers 42, 44 now form a general coiled configuration in the form of aspiral or key ring-type configuration with two loops.

Alternatively, the restraining member 45 may be withdrawn duringimplantation of the device 40 in a patient. Thus, the restraining member45 may be withdrawn when the first and second support members 42, 44have been properly placed allowing the support members 42, 44 to fullyassume the activated shape. This implies that a surgeon may see theresult of the full shape change of the support members 42, 44 duringimplantation of the device 40 and may directly get an indication of thesuccess of the surgery.

As a further alternative, the restraining member may be implemented asone or more bars extending between different positions on the first andsecond support members 42, 44. These bars may thus keep the positions onthe support members 42, 44 at a fixed distance to each other and, inthis way, prevent the support members 42, 44 to fully assume theactivated shape. The bars may be formed from a biodegradable material asdescribed above. Alternatively, the bars may be detached from thesupport members 42, 44 and removed during implantation, or the bars maybe cut during implantation in order to remove the restraining action ofthe bars.

According to an alternative shown in FIGS. 5-6, a device 340 comprises afirst and a second support member 342, 344. The first support member 342is continuous with the second support member 344. The first and secondsupport members 342, 344 are formed from a shape memory material. Thefirst and second support members 342, 344 are coated with abiodegradable sheath 345. During manufacture of the device 340, thefirst and second support members 342, 344 may be immersed in abiodegradable material being in a liquid state. The first and secondsupport members 342, 344 may be immersed into the biodegradable materialin an inactivated, flexible state, while being held in a coil-shape thatmay fit for placing the device within a heart such that the first andsecond support members may conform to the shape of at least a part ofthe valve annulus at opposite sides of the valve. The first and secondsupport members 342, 344 may thus be embedded in a biodegradable sheath345. When the biodegradable sheath 345 is degraded within a patient, thefirst and second support members 342, 344 are allowed to assume theactivated shape, wherein a reduced radius of the coil-shape is obtainedas illustrated in FIG. 6.

According to yet another alternative illustrated in FIGS. 7-8, a device440 comprises a first and a second support member 442, 444. The firstsupport member 442 is continuous with the second support member 444. Thefirst and second support members 442, 444 are formed from a shape memorymaterial. The first and second support members 442, 444 are tubular. Thedevice 440 further comprises an elongate restraining member 445 that maybe arranged extending within the tubular first and second supportmembers 442, 444. The restraining member 445 may be pushed to extendthrough the entire first and second support members 442, 444 in order toforce the first and second support members 442, 444 to a coil-shape witha large radius. By withdrawing the restraining member 445 from insidethe support members 442, 444, the support members 442, 444 are allowedto assume an activated shape wherein the coil-shape has a decreasedradius as illustrated in FIG. 8.

The second support member 44 has an outer boundary which is greater thanthe outer boundary of the first support member 42. The support members42, 44 have corresponding shapes with the second support member 44 beingin larger scale than the first support member 42. This is advantageousin creating a pinch of the valve tissue between the first and secondsupport members 42, 44, as will be described below with reference toFIG. 14. An end of the second support member 44 and the correspondingend of the restraining member 45, which will lead the coil duringinsertion of the device 40 at the valve, has a greater pitch than therest of the coil. This implies that the leading end of the coil duringrotation into position in the valve will project from immediate contactwith the valve tissue and, therefore, the risk that the coil is caughtby the chords is diminished.

The device 40 is shown in cross-section in FIG. 9. The first and secondsupport members 42, 44 have a round cross-sectional shape. Opposedsurfaces 46 of the first and second support members 42, 44 provide apinch to trap valve tissue therebetween. The round cross-section is alsoadvantageous in creating a pinch of the valve tissue which will not harmthe leaflets in their movement during normal heart action, as will befurther described below with reference to FIG. 21.

A device 140 according to a second embodiment of the present inventionis shown in FIGS. 10-12. The device 140 comprises a first and a secondsupport member 142, 144. The first support member 142 is continuous withthe second support member 144. The first and second support members 142,144 are formed from a mesh-type or netlike structure, such as stents.

The first and second support members 142, 144 have an inherentadaptation to a shape change such that an increased cross-section of atleast part of the support member 142, 144 is associated with a shortenedlength of the support member 142, 144. This foreshortening isaccomplished in that the mesh-type structure, when expanded incross-section, pulls the ends of the support members 142, 144 towardseach other.

The support members 142, 144 present a shape change that may becontrolled. The shape change will not occur until a force is applied forincreasing the cross-section of at least part of the first and secondsupport members 142, 144. This implies that the second embodiment aswell as the first embodiment provides a possibility to place a device inrelation to a heart valve and, thereafter, control the point of timewhen the device placed at the heart valve is going to perform a changeof shape.

In FIG. 10, the device 140 is shown with the support members 142, 144arranged in a first shape suitable for being attached to the heartvalve. In this first shape the support members 142, 144 conform to theshape of the heart valve annulus, such that the support members 142, 144may be attached to the annulus along the entire course of the supportmembers 142, 144. The first and second support members 142, 144 form ageneral coiled configuration in the form of a spiral or key ring-typeconfiguration with two loops, such that the support members 142, 144 mayabut opposite sides of a heart valve.

In FIG. 11, the device 140 is shown after the support members 142, 144have been exposed to a force increasing the cross-section of the supportmembers 142, 144. The increased cross-section has forced the supportmembers 142, 144 to shorten. The first and second support members 142,144 now form a coiled configuration having a decreased radius ofcurvature to accommodate to the shortened length of the support members142, 144.

In FIGS. 12a-c , different cross-sections of the first and secondsupport members 142, 144 are illustrated. In FIG. 12a , the supportmembers 142, 144 are tubular having a circular cross-section. In FIG.12b , the support members 142, 144 have a U-shaped cross-section. Boththese cross-sections are suitable for receiving an inflatable ballooninside the cross-sectional structure. Inflation of the balloon will thusforce the cross-section to increase radially. In FIG. 12c , the supportmembers 142, 144 are belt-shaped having a linear cross-section. Thiscross-section may be increased by pulling the edges of the belt apart.

A device 540 according to a third embodiment is shown in FIGS. 13-15.The device 540 comprises a first and a second support member 542, 544.The first support member 542 is continuous with the second supportmember 544. The first and second support members 542, 544 are formedfrom a shape memory material. The shape memory material is treated toform a first and a second activated shape. The first and second supportmembers 542, 544 may thus assume two different shapes depending on thetemperature of the device 540. In an inactivated shape as illustrated inFIG. 13, the device 540 is flexible and may be arranged in an elongateform in order to facilitate introduction of the device to a heart of apatient via a catheter. The device 540 may be cooled during introductionin the catheter in order to maintain its inactivated shape. The device540 may then be heated to a first temperature by utilizing the bodytemperature. Then, the device 540 is brought to the first activatedshape as illustrated in FIG. 14 forming a coil-shape with a large radiussuitable for placing the first and second support members 542, 544 incontact with opposite sides of a heart valve and fixing the position ofthe support members 542, 544 to the valve annulus. The device 540 mayfurther be heated to a second temperature by further utilizing the bodytemperature. Then, the device is brought to the second activated shapeas illustrated in FIG. 15. The device 540 in the second activated shapeforms a coil-shape with a smaller radius suitable for diminishing aradius of the valve annulus.

A device 240 according to a fourth embodiment of the present inventionis shown in FIGS. 16-17. The device 240 comprises only one supportmember 242. The support member 242 is arranged to be placed only on oneside of a heart valve.

The support member 242 may be formed from a shape memory material havingan inactivated shape and an activated shape. In the inactivated shape,the support member 242 is flexible and may be easily deformed. In theactivated shape, the support member 242 has a strong strive towardsassuming a desired, preprogrammed shape. The device 240 may be insertedin a low invasive manner, the support member 242 being in theinactivated shape. The device 240 may then assume the desired shape whenplaced in the proper position in the patient by the support member 242being brought to their activated shape. The device 240 may furthercomprise a restraining member (not shown), which is arranged to preventthe support member 242 from fully assuming the desired activated shape.The restraining member may thus control the point of time when thesupport member 242 is fully brought to its desired activated shape. Thesupport member 242 may be wound around the restraining member or therestraining member may extend between two positions on the supportmember fixating the distance between these positions.

The support member 242 may alternatively be formed from a mesh-type ornetlike structure having an inherent adaptation to a shape change suchthat an increased cross-section of at least part of the support member242 is associated with a shortened length of the support member 242. Thesupport member 242 presents a shape change that may be controlled. Theshape change will not occur until a force is applied for increasing thecross-section of at least part of the support member 242.

According to a further alternative, the support member 240 may be formedfrom a shape memory material treated to form a first and a secondactivated shape.

In FIG. 16, the device 240 is shown with the support member 242 being ina first shape conforming to the shape of the annulus of the heart valveto be treated.

In FIG. 17, the device 240 is shown after the support member 242 hasbeen allowed to perform a change of shape to assume the desired shape.Either a restraining action of a restraining member has been removed ora cross-section of the support member 242 has been increased in order toactivate the shape change. The support member 242 has now changed shapeto decrease a radius of curvature for remodelling the heart valve anddecreasing the size of the heart valve annulus.

Referring now to FIGS. 18-22, a method for repairing a heart valve bymeans of the device according to the first embodiment will be described.The concept of this method may be applied to the device according to thesecond, third or fourth embodiments as well, as would be understood by aperson skilled in the art. As been described above, the shape change ofthe device may be activated in different ways, depending on theembodiment of the device. However, the point of time when the shapechange is activated may be controlled irrespective of which embodimentis used. Thus, it may be ascertained that the device is firmly attachedto the heart valve before the shape change occurs, such that the heartvalve may be properly remodelled as will be described below.

First, access to the heart valve is achieved by means of conventionalcatheter—techniques, including making puncture in a vessel and guidingthe catheter through the vascular system into the heart. In FIG. 18a ,the device 40 is shown when being inserted to the mitral valve 18. Thedevice 40 is being carried in a catheter 50, which extends from theoutside of the patient into the heart. The device 40 may be pushed outof the catheter 50 using a gripping tool (not shown) extending throughthe catheter 50. When pushed out of the catheter 50, the restrainingmember 45 assumes its coil-shape. An end of the restraining member andthe second support member 44 is brought to the opening of the mitralvalve 18 at a commissure between the leaflets 22, 24, as shown in FIG.18b . The end is led through the opening and the device 40 is turned 360degrees. Thus, the second support member 44 will be rotated into placeon one side of the valve 18, whereas the first support member 42 isplaced on the opposite side of the valve 18.

The first and second support members 42, 44 are now brought to theiractivated shape by e.g. heating them above a transition temperature. Theheating may be provided by the body temperature of the patient or bymeans of heating energy being transmitted through a conductor (notshown) in the catheter. This implies that the first and second supportmembers 42, 44 strive towards assuming the preprogrammed shape. Thefirst and second support members 42, 44 on opposite sides of the valvewill now be drawn towards each other for securely trapping valve tissuetherebetween. The restraining member 45 will prevent the first andsecond support members 42, 44 from fully assuming the activated shapeand, thus, from reducing the radius of curvature of the coil-shape. Inthis way, the device 40 is arranged in engagement with the valve 18, asshown in FIG. 19.

The support members 42, 44 are now placed on opposite sides of the valve18 pinching valve tissue therebetween to maintain a shape of the valve18. The support members 42, 44 may have roughened, opposed surfaces 46to better keep the leaflets 22, 24 from slipping through the pinch. Thisimplies that the position of the support members 42, 44 relative theheart valve is initially fixed.

The device 40 may now be secured to the valve 18 for strengthening thefixation of the relative position between the support members 42, 44 andthe valve tissue. The support members 42, 44 may comprise respectivebores 54 through the opposed support members for receiving separatefasteners 56. The fasteners 56 may be threaded or unthreaded pins andmay be pushed into position extending through bores in both supportmembers and valve tissue therebetween. The fastener may have an end 58with larger diameter than the bores 54 such that the fastener 56 may notfall through the bore 54. In this way, the device 40 is firmly attachedto the valve 18 for keeping the valve annulus 20 in its reshaped form,as illustrated in FIG. 20a . Many alternative embodiments of thefasteners may be contemplated. As shown in FIG. 20a , the fasteners 56may have an end 60 with an expandable diameter for securing the fastener56 after it has been pushed through the bores 54. Alternatively, thefastener 56′ may have a curved portion 60′ for gripping around one ofthe support members, such that the fastener 56′ may extend through abore 54 in one support member and around the other support member, asillustrated in FIG. 20b . As further alternatives, the fasteners may beclips, sutures, or projections that are extendable from at least one ofthe support members for engaging the valve tissue.

As illustrated in FIG. 21, the second support member 44 is slightlydisplaced radially with respect to the first support member 42. Thisimplies that the first and second support members 42, 44 are notarranged directly on top of each other. The pinch between the first andsecond support members is therefore not sharply defined in a radialdirection of the valve. This implies that a pinching force between thesupport members is not focussed to a specific radial position of thevalve. As a result, the pinching force does not affect the movement ofthe leaflets during normal heart action and there is a diminished riskof rupture in the leaflets at the pinch. The support members areinterrelated in such manner that the outer boundary of the first supportmember 42 has a diameter corresponding to a line through the center ofthe second support member 44. Thus, the support members 42, 44 overlapsomewhat such that tissue is not allowed to move through the pinch andthe shape of the valve is maintained. Further, the cross-section of thesupport members 42, 44 is round, which also gives a soft contact betweenthe support members and the valve tissue to further diminish the risk ofrupture in the leaflets.

After the device 40 has been placed at the heart valve forming a pinchof the valve tissue, the catheter 50 will be retracted and the device 40is left in the patient. The restraining member 45 will be degraded inthe patient during a time period of a few weeks. During this time, thesupport members 42, 44 will grow into the valve tissue for furthersecuring the support members 42, 44 to the valve. When the restrainingmember 45 has been degraded, the support members 42, 44 are able tofully assume the activated shape. Thus, the support members 42, 44 willreduce the radius of curvature of the coil-shape and bring the pinchedvalve tissue in the shape change so as to remodel the valve, asillustrated in FIG. 22. The leaflets 22, 24 are thus brought closertogether for ensuring that they may close the valve properly.

It should be emphasized that the preferred embodiments described hereinare in no way limiting and that many alternative embodiments arepossible within the scope of protection defined by the appended claims.

For example, the access to the heart valve may be achievedendoscopically or with open heart surgery. In such case, the device 40may have a coil-shape already during insertion into the heart.

Many different shapes may be contemplated for the loop-shaped supportmembers. For example, the support members may have elliptical, circularor D-shaped forms. One or both support members need not make an angularturn of 360° such as to have a C or U-shape instead.

Further, different shape changes may be contemplated. The course of thesupport member may be changed such that a radius of curvature isincreased locally. Further, the course of the support member may bechanged to introduce a depression or recess in the course of the supportmember.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A method for improving the function of a heartvalve comprising: obtaining a support member, wherein the support memberis comprised of a first segment and a second segment; inserting saidfirst segment to abut a superior or inferior side of the valve and tosubstantially conform along a first course of said first segment to ashape of at least part of an annulus of the valve and inserting saidsecond segment to abut an opposite inferior or superior side of thevalve and to substantially conform along a first course of said secondsegment to a shape of at least part of the valve annulus at saidopposite side; fixating a position of the support member relative to thevalve; changing the shape of the support member into an altered courseof reduced diameter by expanding a cross-section of the support membersuch that a length of the support member is shortened so as to remodelthe heart valve; wherein said fixating step is performed prior to saidchanging step.
 2. The method according to claim 1, wherein saidexpanding said cross-section includes inflating a balloon against atleast a part of said support member.
 3. The method according to claim 1,wherein the first and second segments are formed from a mesh-likestructure.
 4. The method according to claim 1, wherein said fixatingcomprises trapping valve tissue between said first and second segments.5. The method according to claim 1, wherein said changing the shape ofthe support member further comprises changing the shape of both thefirst and second segment into said altered course.
 6. The methodaccording to claim 1, wherein said inserting further comprisesintroducing a first end of the first segment through a portion of thevalve tissue, rotating the support member so that the first segment ison said superior or inferior side of the valve, and positioning thesecond segment on said opposite superior or inferior side of the valve.7. The method according to claim 1, wherein the step of insertingfurther comprises introducing said support member into a patient insidea catheter.
 8. The method according to claim 1, wherein said changingthe shape further comprises allowing said first and second segment tochange into a memory induced shape.
 9. The method according to claim 1,wherein the first and second segments are belt-shaped.
 10. The methodaccording to claim 1, wherein the first and second segments have aU-shaped cross-section.
 11. The method according to claim 1, wherein thefirst and second segments are tubular.
 12. The method according to claim1, wherein the first segment is continuous with the second segment toform a coil-shape.
 13. A method for improving the function of a heartvalve comprising: obtaining a support member, inserting said supportmember to abut one side of the valve and to substantially conform alonga first course of said support member to a shape of at least part of anannulus of the valve, fixating a position of the support member relativeto the valve, changing the shape of the support member into an alteredcourse of reduced diameter so as to remodel the heart valve by expandinga cross-section of the support member such that a length of the supportmember is shortened; wherein said fixating step is performed prior tosaid changing step; wherein the support member is arranged to assume areduced radius of curvature in said altered course.